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TerminatedNCT01384747Updated Jun 20, 2018

Effect of Fimasartan for Modification of Atheroma Vulnerability in DEFERred Coronary Disease (FIMA-DEFER)

A Phase 4 interventional study of Fimasartan and Placebo in Coronary Artery Disease, sponsored by Seung-Jung Park. Terminated at 3 sites in Korea, Republic of. Open to participants aged 19 Years to 84 Years. Per ClinicalTrials.gov, last updated 2018-06-20.

Sponsored by Seung-Jung Park · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
186
Allocation
Randomized
Ages
19 Years to 84 Years
Sex
All
01

Study summary

  • Fimasartan will be more beneficial in stabilizing the plaque vulnerability compared to control group in deferred coronary lesions.
  • Fimasartan will be more beneficial in reducing total plaque volume compared to control group in deferred coronary lesions.
  • Fimasartan will be more beneficial in reducing functional impairment of stenotic lesions (assessed by FFR:Fractional Flow Reserve) in deferred coronary lesions.
Read the detailed description

Prospective, double-blind, randomized clinical study with enrollment of patients over at least 18 years of age who require coronary angiography for a clinical indication with hypertension defined as systolic blood pressure >140mmHg or diastolic blood pressure >90mmHg. Inclusion requires at least one deferred coronary lesion with 1) visually-estimated angiographic %diameter stenosis 20-50% or 2) %diameter stenosis >50% without any evidence of inducible ischemia. The target vessel for IVUS interrogation must not have undergone angioplasty (deferred lesion) nor have more than 50% luminal narrowing throughout a target segment. Patients meeting inclusion criteria without any exclusion criteria will be randomized 1:1 (Fimasartan 60-120 mg vs placebo). All subjects will be followed up at 1 year for serial VH-IVUS and conventional IVUS evaluation. Also, OCT sub-study will be performed in selected patients with lesions at least 20 mm distally located from coronary ostium. All patients will be blindly assigned to control and Fimasartan once daily as 1:1 ratio and are prescribed for 1year.

02

Conditions studied

03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 186 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Seung-Jung Park is the lead sponsor of 82 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 84 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Hypertensive patients (systolic blood pressure >140mmHg or diastolic blood pressure >90mmHg) or medically treated hypertension with normal blood pressure who undergo coronary angiography with clinical indications
  2. 18 \< Age \< 85
  3. Patient who has received informed consent
  4. at least one deferred coronary lesion with 1) visually-estimated angiographic %diameter stenosis 20-50% or 2) %diameter stenosis >50% without any evidence of inducible ischemia (FFR ≥ 0.8 or negative perfusion defect on thallium scan or negative treadmill test)

Exclusion criteria

Exclusion Criteria:

  1. Planned cardiac surgery (e.g., CABG, valve repair or replacement, or aneurysmectomy) or planned major non-cardiac surgery within the study period
  2. Planned performance of PCI or CABG in the target vessel or its branches containing the index
  3. Evidence of congestive heart failure, or left ventricular ejection fraction \< 40%
  4. Stroke or resuscitated sudden death in the past 6 months
  5. Chronic disease requiring treatment with oral, intravenous, or intra-articular corticosteroids (use of topical, inhaled, or nasal corticosteroids is permissible)
  6. A diagnosis of cancer (other than superficial squamous or basal cell skin cancer) in the past 3 years or current treatment for the active cancer
  7. Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study
  8. Significant renal disease manifested by serum creatinine > 1.5 mg/dL
  9. Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (ALT or AST > 3 times upper limit of normal)
  10. Active hepatitis B or C or carrier
  11. Hypotension (systolic blood pressure \<90 mmHg)
  12. Patients already taking ACE inhibitors or ARBs
  13. Patients with STEMI requiring primary PCI
  14. Patients pregnant or breast-feeding or child-bearing potential
  15. Patients who are lack of intention for effective contraception
  16. Patients with history of previous enrollment into a clinical trials within 3 months
  17. Allergic or contraindicated to Angiotensin II antagonists
  18. History of any arterial bypass or angioplastic intervention involving the target vessel
  19. Luminal narrowing in the left main > 50% by visual inspection of angiogram
  20. Visually-estimated angiographic reference segment diameter of \<2.75mm or >4.0 mm
  21. Presence of thrombus or complex plaque morphology in the target vessel that suggests a high likelihood of distal embolism
  22. Severe tortuosity of the target vessel or any other anatomical reasons that the investigator deems
  23. Inappropriate for IVUS procedures. Vessel with thrombus (on GS-IVUS), moderate or severe calcification, angulation
  24. Culprit vessel in AMI
  25. RWMA (Regional Wall Motion Abnormality) or scar tissue in the territory subtended by the studied lesion
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
186 participants (actual)

Study arms

  • Experimental
    Fimasartan

    Initial dose will be started with 60mg per day. At 4 week follow-up after the procedure, dose titration upto 120 mg per day will be made if the patient is not hypotensive.

    Drug: Fimasartan

  • Placebo comparator
    Placebo

    Initial dose will be started with 60mg per day. At 4 week follow-up after the procedure, dose titration upto 120 mg per day will be made if the patient is not hypotensive.

    Drug: Placebo

Interventions

  • DrugFimasartan

    60-120mg/day (target dose) of Fimasartan will be administered for the study period (till the follow-up angiography)

    Also known as: Kanarb Tab.

  • DrugPlacebo

    60-120mg/day (target dose) of Placebo will be administered for the study period (till the follow-up angiography)

06

What researchers measure

Primary outcomes

  1. Change in percent necrotic core (NC) volume of plaque by VH (Virtual Histology) in the "target segment" (within deferred vessel)

    Time frame: baseline and 1 year

Secondary outcomes

  1. Change of total atheroma volume (TAV) and percent atheroma volume (PAV) of the target segment and the most diseased 10-mm segment (normalized to different segment length) with the largest plaque volume

    Time frame: baseline and 1 year

  2. Percent change in minimal lumen area (MLA) in target segment

    Time frame: baseline and 1 year

  3. Change of absolute area or percentages (%) of each plaque VH composition (fibrotic, fibrofatty, dense calcium, necrotic core) at minimal lumen area (MLA) and largest necrotic core area within the target segment

    Time frame: baseline and 1 year

  4. Change of VH-IVUS (Intra Vascular UltraSound) detected plaque type from baseline

    Time frame: at 1 year

  5. Change of percentage (%) of OCT (Optical Coherence Tomography)-defined TCFA (Thin Cap Fibrotic Atheroma) within the target segment from baseline

    Time frame: at 1 year

  6. Change of composition of OCT-defined fibrous, fibro-calcific, and lipid-rich plaque within the target segment

    Time frame: baseline and 1 year

  7. Change of OCT-defined fibrous cap thickness, the presence of plaque disruption, calcification or intraluminal thrombus within the target segment

    Time frame: baseline and 1 year

  8. Change of FFR in target segment from baseline

    Time frame: at 1 year

  9. systolic and diastolic blood pressure

    Time frame: at 1 year follow-up

  10. Change in high sensitive CRP (C-Reactive Protein)from baseline

    Time frame: at 1 year

07

Study locations

3 sites
  • Chonnam National University Hospital
    Gwangju, 501-757, Korea, Republic of
  • Asan Medical Center
    Seoul, 138-736, Korea, Republic of
  • Ulsan University Hospital
    Ulsan, 682-714, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No — This is not a publicly funded trial.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 20, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01384747
Lead sponsor
Seung-Jung Park
Collaborators
CardioVascular Research Foundation, Korea, Boryung Pharmaceutical Co., Ltd
Responsible party
Seung-Jung Park (MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine, CardioVascular Research Foundation, Korea) — Sponsor-investigator
First posted
Jun 29, 2011
Start date
Jul 2011
Primary completion
Mar 2018
Completion
Mar 2018
Last update
Jun 20, 2018

Study contacts

Seung-Jung Park, MD, PhD
principal investigator · Asan Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

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